[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.37]
[Page 255]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 26 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
Subpart B Specific Sector Provisions for Medical Devices
Sec. 26.37 Confidence building activities.
(a) At the beginning of the transitional period, the Joint Sectoral
Group will establish a joint confidence building program calculated to
provide sufficient evidence of the capabilities of the designated
conformity assessment bodies (CAB's) to perform quality system or
product evaluations to the specifications of the parties.
(b) The joint confidence building program should include the
following actions and activities:
(1) Seminars designed to inform the parties and CAB's about each
party's regulatory system, procedures, and requirements;
(2) Workshops designed to provide the parties with information
regarding requirements and procedures for the designation and
surveillance of CAB's;
(3) Exchange of information about reports prepared during the
transition period;
(4) Joint training exercises; and
(5) Observed inspections.
(c) During the transition period, any significant problem that is
identified with a CAB may be the subject of cooperative activities, as
resources allow and as agreed to by the regulatory authorities, aimed at
resolving the problem.
(d) Both parties will exercise good faith efforts to complete the
confidence building activities as expeditiously as possible to the
extent that the resources of the parties allow.
(e) Both the parties will each prepare annual progress reports which
will describe the confidence building activities undertaken during each
year of the transition period. The form and content of the reports will
be determined by the parties through the Joint Sectoral Committee.
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